New research suggests the stepwise algorithm can lead to improved satisfaction and lower treatment doses.
Allowing patients to play a larger role in deciding when to change the level of asthma treatment they receive leads to improved satisfaction without increasing risk.
The pharmacological management of asthma often uses a stepwise approach to treatment, where treatment intensity is adjusted according to how well symptoms are controlled.
Algorithms used to guide this stepwise process typically have five different steps, but in recent years the Global Initiative for Asthma (GINA) has preferred a more streamlined three-step “anti-inflammatory reliever” (AIR) approach.
While there is ample safety and efficacy data for each step in treatments in the individual steps of such plans, less attention has been given to how the AIR algorithm is implemented.
Now, a new open-label trial has revealed that using the AIR algorithm to manage asthma in adults results in improved patient satisfaction and reduced levels of treatment – without affecting patient safety or lung function. The results were published in eClinicalMedicine.
“This study shows how ICS-formoterol reliever ± maintenance therapy may be implemented in clinical practice, through a practical stepwise algorithm, in which treatment steps are adjusted in response to reliever use and asthma attacks,” the researchers wrote.
Ninety-nine people with asthma (68% females, mean age 48 years, mean prescribed dose of ICS at baseline 454.5 micrograms/day) completed the study. Participants could be using SABA reliever monotherapy, ICS maintenance with SABA reliever therapy or ICS-long-acting beta2-agonist (LABA) maintenance plus SABA reliever therapy to control their symptoms.
Patients who had used budesonide-formoterol Single Maintenance and Reliever Therapy (SMART), leukotriene receptor antagonists, long-acting muscarinic antagonists, theophylline, regular oral corticosteroids, sodium cromoglycate or nedocromil sodium or monoclonal antibody therapy in the last three months were excluded, as were patients who had been admitted to ICU for asthma care or who also had COPD.
The researchers recruited an even spread of patients from each of the first four GINA steps (ranging from SABA reliever alone [step 1] through to medium or high dose ICS-LABA plus SABA reliever [step 4]), and patients were assigned to one of three AIR treatment steps based on their GINA classification.
AIR step 1 involved using one actuation of an ICS-LABA reliever as required to relieve asthma symptoms, AIR step 2 was one actuation of low dose ICS-LABA SMART twice daily, plus an additional actuation as required, while AIR step 3 was two actuations of medium dose ICS-LABA SMART twice daily plus an additional actuation as required.
During the first six months the decision to change treatment steps was initiated by an investigator based on how frequently patients were using their reliever and whether they were experiencing asthma attacks, but during the last six months these decisions were led by the patients.
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Patients were given specific instructions about when to change the treatment step. If they used two or less actuations per week for symptom relief they could step down one level of treatment (if possible), if they used more than two but no more than seven actuations per week they continued with their current treatment, but if they required more than seven actuations per week or had an asthma attack they stepped up to a more intense treatment step.
The primary outcome – patient satisfaction at week 52, measured by the Global Satisfaction domain of the Treatment Satisfaction Questionnaire for Medication (TSQM-II, where scores range from 0-100 and higher scores represent higher levels of patient satisfaction) – showed an improvement. The mean (standard deviation [SD]) at week 52 was 84.3 (18.6) compared to 78.1 (14.7) at baseline.
There was a general shift towards the lower treatment steps over the course of the trial, with 59.6%, 30.8% and 9.6% of patients in steps 1, 2 and 3 (respectively) of the AIR algorithm at 52 weeks compared to the 25%, 50% and 25% in each group at baseline.
The proportion of investigator- and patient-led treatment step changes were similar. Most patients felt that their AIR treatment was somewhat or much better than their previous treatment at week 26 (74.7%) and week 52 (80.8%). While there were four serious adverse events during the trial, including an acute cardiac event, none of the events were related to the treatment.
“Despite this down-titration, there was a significant improvement in asthma symptom control and quality of life, though the magnitude of these changes did not meet the established cut points for [a minimal clinically important difference]. There was no deterioration in lung function or change in FeNO from baseline,” the researchers concluded.
